Our consultancy activities include:
1. Regulatory Affairs
The markets on which the companies put their own products are characterized by laws and standards that define the conditions to be satisfied in the different situations; we carry out product and system consultancy activity to help the companies meeting these requirements.
The Regulatory Affairs consulting activity includes:
– identification of the applicable European Directives / Regulations and of the most convenient procedures for affixing the CE marking, building up the products technical file and implementing the requested system measures
-identification of the current rules in different exporting countries (e.g. USA, Russia, etc.) by supporting the company in the implementation of the measures needed to place the products on those markets.
These activities relate to different type of product for which there are regulations at European level or in other markets of interest.
– CE marking and clearance FDA of a medical device or an IVD, including the definition and implementation of the system measurement (ISO 13485, GMP)
– AIC (Marketing Authorization *) approval of a medication or prescription
– production and logistic planning according to GMP and GDP standards.
2. Development and maintenance of management systems
This activity can be addressed both to the initial development and to the following maintenance and update of the management systems, based on the general standards for:
– quality (ISO 9001)
– competence of laboratories (ISO / IEC 17025 )
– medical devices (ISO 13485)
– pharmaceutical industry (GMP)
– aeronautics, space and defense (ISO 9100).
We can support your staff, or we can offer you an outsourcing solution, to give you all the benefits of a professional solution without spending your organization time and resources.
3. Managerial consulting
We realize consulting services on specific issues related to:
– company structure
– organizational solutions
– Internal and external audit for assessment of conformity and adequacy
– Business Process Re-engineering
For further clarifications and information please contact the contact desk.